TerminatedEarly Phase 1

Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars

Stopped: The PI moved to another Institution

United States168 participantsStarted 2008-07

Plain-language summary

The overall goal of this study is to determine the efficacy of tocotrienol (TCT), a natural form of vitamin E, in preventing or reducing scar formation in human skin wounds as well as the basal levels of TCT in normal human skin and adipose tissue.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age or older. * Non- smoker * No current medications that alter liver metabolism (e.g., Phenobarbital, HmG co-A inhibitors, etc.) * Non- pregnant or non-breastfeeding * No current use of dietary supplements containing vitamin-E * Not actively abusing drugs or alcohol Exclusion Criteria: * Under 18 years of age * Prisoners * Current smoker * Pregnant or breastfeeding * HIV diagnosis * Viral hepatitis diagnosis * Immunosuppressive therapy * Actively abusing drugs or alcohol * Current use of dietary supplements containing vitamin-E

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1.To determine the efficacy of TCT in improving the appearance of post-surgical scars following oral supplementation 2.To determine the efficacy of TCT in improving the appearance of post-surgical scars following topical application

Timeframe: 4 weeks prior to surgery and 12 weeks post surgery.

Trial details

NCT IDNCT00700791

SponsorChandan K Sen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07

View on ClinicalTrials.gov More Scar trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.